Every new year, we can expect changes—often at a surprisingly rapid rate. This is especially true with new rules and regulations. For instance, in 2024, as part of the Modernization of Cosmetic Regulation Act of 2022 (MOCRA), the FDA significantly expanded its authority. And many companies are rushing to ensure their products and processes are ready.
The new laws were created to help increase consumer safety for products they use often—even daily. They do, however, mean companies in the beauty industry need to be prepared and get ahead of the changes. Some requirements have already been rolled out in 2023, and more are being released in 2024. Is your company ready for these new FDA regulations?
New FDA Regulations
- Updated labeling requirements, including contact information (address, phone number, website, or email) for customers to report adverse events. The FDA will also be releasing a list of fragrance allergies that must be identified if they’re found within the product.
- New facility registration with the FDA within 60 days of starting operations and renewed registration every two years.
- Product listings for every product marketed as well as the ingredients found in the product. Every year, the list must be updated.
- Safety records and documentation, including the scientific data used to support the product’s safety. Notably, animal testing is not required for cosmetic products.
- Adverse event reporting to the FDA within 15 business days with any new information on the event reported within a year of the initial account.
- Mandatory recall authority by the FDA if any cosmetics are determined to be serious health risks to customers if the company does not voluntarily recall the product.
- Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products.
There are, however, exemptions for small businesses for GMP, registration, and product listings unless those products regularly come in contact with the delicate tissues of the eye, if the products are injected, if they are intended for internal use, or if they alter the appearance for over 24 hours.
This increased oversight for improved product safety and manufacturing processes can feel overwhelming at times. Especially as there are real consequences for companies found to be out of compliance.
How Your Fulfillment Partner Can Help
Fortunately, you don’t have to navigate all of these changes alone. The right fulfillment partner can play a vital role in helping your company comply with:
- Label review and management to ensure all products are labeled according to the new requirements, such as including contact information for adverse events and fragrance allergens as that information is crucial for your customers’ safety.
- Detailed inventory tracking and documentation, including manufacturing and expiration dates, lot numbers, and other info that’s vital for traceability and accountability, especially if there’s a recall or adverse event report.
- GMP adherence, ensuring the products are handled throughout the fulfillment process per the FDA guidelines.
- Adverse event reports and communication within a timely manner.
- Facility registration for new cosmetic companies or those that are expanding their operations, helping ensure regulatory timelines and requirements are met.
- Assistance with product and ingredient listings to help you ensure all products are properly registered and updated.
- Safety data and documentation to help ensure you maintain substantiation records for your beauty products.
- Education and compliance updates to help you stay on top of any regulatory changes, as well as support and guidance through the process as the FDA standards evolve.
- Special considerations for small or growing businesses, so you know when you’re exempt or your company has grown to such a point that more requirements must be complied with.
With the help and expertise of the right fulfillment partner and dedicated account manager, you can more effectively navigate the growing complexities of the new FDA regulations.
Contact QuickBox today to help ensure your products remain safe, compliant, and ready to land on your customer’s doorsteps. We don’t make you fit into our “Box”—we build a “Box” to meet your changing needs!